Safety and Pharmacokinetics Study of a New Drug for Type 2 Diabetes

April 18, 2016 updated by: Genmedica Therapeutics S.L.

A Double-Blind, Placebo-Controlled, Randomised, Two Part Study of the Safety and Pharmacokinetics of GMC-252 in A) Healthy Male Subjects, Including a Comparison of GMC-252 Dosing in the Fed and Fasted States ,and B) in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to determine the toxicity, tolerability and safety of single ascending doses of GMC-252-L-Lysine Salt in healthy male subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Merthyr Tydfil, United Kingdom, CF48 4DR
        • Simbec Research Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Body Mass Index (BMI) within the range of 18-35 kg/m2 inclusive. BMI = Body weight (kg) / [Height (m)]2.
  • Diet: Able to eat standard food, no vegetarians.
  • Compliance: Understood and was willing, able and likely to comply with all study procedures and restrictions.
  • Consent: Demonstrated understanding of the study and willingness to participate as evidenced by voluntary written informed consent and had received a signed and dated copy of the Informed Consent Form.
  • Had no known hypersensitivity to diflunisal, NAC (N-acetylcysteine) or other non-steroidal anti-inflammatory drugs (NSAIDs).
  • Had no known peptic ulcer diseases.
  • Had an estimated creatinine (CREA) clearance ≥ 50 mL/min (Creatinine clearance was calculated from the serum CREA value using the Cockroft & Gault formula).
  • Had no history of heart failure or uncontrolled hypertension or other known overt cardiovascular disease.
  • Had no history of 'Aspirin Triad' (chronic rhinosinusitis with polyps, severe asthma and intolerance to aspirin or other NSAIDs).
  • Had no marked abnormality of liver tests before entry into the study.
  • Male subject willing to use an effective method of contraception, if applicable (unless anatomically sterile or where abstaining from sexual intercourse was in line with the preferred and usual lifestyle of the subject) from Day 1 until 3 months afterwards.
  • Subject with no clinically significant abnormal serum biochemistry, haematology and urine examination values at the Screening Visit.
  • Subject with a negative urinary drugs of abuse screen (a positive alcohol result could have been repeated at the discretion of the Investigator).
  • Subject with negative human immunodeficiency virus (HIV) and Hepatitis B (Hep B) and Hepatitis C (Hep C) results.
  • Subject with no clinically significant abnormalities in 12-lead ECG at the Screening Visit.
  • Subject was available to complete the study (including all Follow-up Visits).
  • Subject satisfied a medical examiner about their fitness to participate in the study.
  • Subjects were non-smokers and non-alcohol drinkers or drank alcohol in moderation (e.g. ≤ 14 units/week).

Exclusion Criteria:

  • A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
  • Receipt of regular medication at the Screening Visit that may have had an impact on the safety and objectives of the study (at the Investigator's discretion).
  • Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
  • A clinically significant history of previous allergy/sensitivity to GMC-252.
  • A clinically significant history of drug or alcohol abuse.
  • Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
  • Participation in a New Chemical Entity clinical study within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks. (N.B. washout period between trials defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
  • Donation of 450 mL or more blood within the previous 12 weeks.
  • Receipt of any medication since the Screening Visit that may have had an impact on the safety and objectives of the study (at the Investigator's discretion).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort A (Part A)

Single ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo

Interventions:

Drug: GMC-252-L-Lysine Other: Placebo
Other: Placebo
Drug: GMC-252-L-Lysine
Experimental: Cohort B (Part A)

Single ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo

Interventions:

Drug: GMC-252-L-Lysine Other: Placebo

The dose administered in Part A (fed) was based on the outcome of Part A (fasted).
Other: Placebo
Drug: GMC-252-L-Lysine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame: Over a 14 days period post dose
Physical status (Vital signs; 12-lead ECG; Urinalysis; Haematology and biochemistry)
Over a 14 days period post dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Maximal Concentration (Cmax)
Time Frame: Over a 14 days period post dose
Over a 14 days period post dose
Area Under the Concentration-Time Curve
Time Frame: Over a 14 days period post dose
Over a 14 days period post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genmedica Therapeutics S.L.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Simbec Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Salvatore Febbraro, MBBS, Simbec Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GMC-252-1.02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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